Engineer I, Validation

Serán is seeking an Engineer Associate or Engineer I to support validation activities associated with pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. This position is a crucial role in maintaining, scheduling, and executing qualification and validation activities for the manufacturing of tablets, capsules and spray drying dispersion for the use of clinical FDA trials. The successful candidate will support all facets of the validation life cycle including design, operation, continuous improvement, and decommissioning of manufacturing equipment. Preference will be given to candidates with pharmaceutical industry experience within a GMP environment to best inform decisions and provide direction for the assurance of product quality.

While industry experience is preferred, those with minimum education and experience are encouraged to apply. Serán seeks applicants who demonstrate an aptitude to apply their engineering education and background to a new industry and gaining experience in cGMP regulatory environment. Job title and salary commensurate on experience within pharmaceutical industry.

Duties & Responsibilities

Required Skills and Abilities

• Authors qualification and validation protocols and reports
• Demonstrates mechanical aptitude with a proven ability to problem-solve
• Strong analytical skills with the ability to interpret technical data and equipment performance trends
• Excellent written communication skills for generating clear, compliant documentation
• Ability to work collaboratively with cross-functional teams in a client-driven environment
• Strong verbal and written communication skills
• Excellent organizational skills with attention to detail and commitment to documentation accuracy
• Ability to prioritize work independently and ask for assistance when appropriate
• Ability to focus in a fast-paced environment with shifting priorities
• Proficient with Microsoft Suite or related software, with the ability to learn new QMS systems 

Education & Experience

Physical Requirements

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701